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Ambu A/S

US

Last updated May 24, 2026

Information

Country
US
Address
—
Website
ambuusa.com
LinkedIn
—
Facebook
—
Phone
+14107686464
PRRC Contact
—
EUDAMED SRN
—
FDA FEI Number
—
DUNS Number
305682023

Catalogue (1294)

Page 16 of 26
DeviceModel / ReferenceRegistriesClassStatus
Neuroline CupNeurology Surface Electrode 72615-M-CM-10
FDA UDI
Class IIUnknown
Antimicrobial DressingStand alone, complementary accessory (to be used 418100501
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520615000
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 524611031
FDA UDI
Class IIActive
BlueSensor RECG Electrodes R-00-S/25
FDA UDI
Class IIActive
Ambu® ACTion™ Block Pump 418203400C
FDA UDI
Class IIActive
Ambu® aScope™ 5 Broncho 4.2/2.2 620001000US
FDA UDI
Class IIActive
Ambu WhiteSensor WS WS-00-S/RT/5
FDA UDI
Class IIUnknown
aScope BronchoSampler™ 60 SC 480500000US
FDA UDI
Class IActive
BlueSensor NECG Electrodes N-00-F/25
FDA UDI
Class IIUnknown
Ambu WhiteSensor 4540ECG Electrodes 4540
FDA UDI
Class IIUnknown
aScope™ 4 Cysto 601001000
FDA UDI
Class IIActive
Ambu WhiteSensor WSECG Electrodes WS-00-S/4
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 530614800
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 522611000
FDA UDI
Class IIActive
Ambu® SPUR® II Infant Resuscitator 544212031
FDA UDI
Class IIActive
King Mask 1443
FDA UDI
Class IActive
Neuroline MonopolarNeurology Needle Electrodes 74350-45/40
FDA UDI
Class IIActive
SPUR® II Pediatric Resuscitatorw/PEEP Valve 20 530215001
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorMask/no wrap 520611019
FDA UDI
Class IIActive
SleepmateThermistor AirFlow, Battery Kit 814950-100
FDA UDI
Class IIUnknown
SleepmateDisposable AirFlow Sensor, Adult 814303-000/20
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520211048
FDA UDI
Class IIActive
SleepmateOne Channel Thermistor, Adult (Cable, Interface & 10 sensors) 814903-000
FDA UDI
Class IIActive
Res-Cue Key Refill-Pack 248001000
FDA UDI
Class IIActive
Mark IV Baby Resuscitator 299004000
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530613054
FDA UDI
Class IIActive
aScope™ 3 Large 5.8/2.8Flexible Videoscope - Single Use 414001000
FDA UDI
Class IIUnknown
Airflow Thermistor PediatricSleepmate 1420402
FDA UDI
Class IIUnknown
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 520211061
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530213830
FDA UDI
Class IIActive
Ambu Subdermal CorkscrewSingle Patient Probes 74715-60/24
FDA UDI
Class IIActive
ACTion Fuser Pump, 400ml, 1-6 ml/hrMultiBolus, 140mm caut-to-size cath 418101400
FDA UDI
Class IIActive
SleepmateInductance Belt Abdomen Kit, Infant 819001-100
FDA UDI
Class IIUnknown
Ambu® SPUR® II Pediatric Resuscitator 530211000
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 530619000
FDA UDI
Class IIActive
SleepmateCannula Oral/Nasal, Case of 25 814320-000/25
FDA UDI
Class IIUnknown
SPUR® II Pediatric ResuscitatorSingle Patient Use Resuscitator 531638000
FDA UDI
Class IIActive
Mark IV Resuscitatorwith single shutter patient valve 304004000
FDA UDI
Class IIActive
Mark III MIL Resuscitatorwith butyl rubber outer cover and Mark III pa A233003000
FDA UDI
Class IIActive
Catheter Set, 190mm Cut-to Size (36" tube), 9" Introducer 418000535
FDA UDI
Class IIActive
Ambu® SPUR® II Adult Resuscitator 520611014
FDA UDI
Class IIActive
SPUR® II Adult ResuscitatorSingle Patient Use Resuscitator 523611057
FDA UDI
Class IIActive
SPUR® Pediatric Resuscitator 530213051
FDA UDI
Class IIActive
CareFusion Snoring Sensor 69332
FDA UDI
Class IIUnknown
SPUR® II Pediatric Resuscitatorw/ Manometer 530614030
FDA UDI
Class IIActive
Ambu® SPUR® II Pediatric Resuscitator 531613016
FDA UDI
Class IIActive
aScope™ 4 Broncho Regular 5.0/2.2 477001000
FDA UDI
Class IIActive
SPUR® II Infant ResuscitatorSingle Patient Use Resuscitator 544211047
FDA UDI
Class IIActive
RIP Thorax Processor - EmblaSleepmate 1421047
FDA UDI
Class IIUnknown

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